Left Atrial Appendage Ligation in Nonvalvular Atrial Fibrillation Patients at High Risk for Embolic Events With Ineligibility for Oral Anticoagulation

Sievert, Horst; Rasekh, Abdi; Bartus, Kryzstof; Morelli, Remo; Fang, Qizhi; Kuropka, Jonas; Le, Duong; Gafoor, Sameer; Heuer, Luisa; Safavi‐Naeini, Payam; Hue, Trisha F.; Marcus, Gregory M.; Badhwar, Nitish; Massumi, Ali; Lee, Randall J.

doi:10.1016/j.jacep.2015.08.005

Cited by 38 publications

(31 citation statements)

References 48 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…13 To date, the Lariat has not been involved in any prospective randomized trials, but published clinical results for single-center studies (together with a recent multicenter study) provide insight into the potential of the Lariat as a method of LAA closure, as well as insight into the potential for protection against stroke (Table I). [13][14][15][16][17] These study results indicate consistent trends of eff icacy and safety for LAA closure, which warrant further evaluation of the Lariat in a multicenter prospective randomized trial. Sievert and colleagues 17 conducted a 5-center study that evaluated the use of Lariat for patients who had contraindications to OAC therapy, such as histories of bleeding, stroke/transient ischemic attack, or cerebral aneurysm.…”

Section: Lariat Studiesmentioning

confidence: 65%

“…[13][14][15][16][17] These study results indicate consistent trends of eff icacy and safety for LAA closure, which warrant further evaluation of the Lariat in a multicenter prospective randomized trial. Sievert and colleagues 17 conducted a 5-center study that evaluated the use of Lariat for patients who had contraindications to OAC therapy, such as histories of bleeding, stroke/transient ischemic attack, or cerebral aneurysm. There were 6 deaths during this study's 2-year follow-up period, one of them procedure-related because of a pulmonary embolus one day after the procedure.…”

Section: Lariat Studiesmentioning

confidence: 65%

“…Several retrospective multicenter studies of experiences with the Lariat device have confirmed high acute procedural success rates. 13,[15][16][17] The role of LAA ligation in reducing AF burdens in patients who display persistent AF must be further evaluated in a multicenter prospective study. The role of Lariat in the treatment of a targeted population with persistent AF is currently under investigation.…”

Section: Resultsmentioning

confidence: 99%

See 2 more Smart Citations

Where We Stand on Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation

Safavi‐Naeini¹,

Rasekh²

2016

Texas Heart Institute Journal

Self Cite

View full text Add to dashboard Cite

A trial fibrillation (AF) is the most prevalent cardiac arrhythmia-found in 1% to 2% of the general population.1 It is also a major cause of ischemic stroke. Patients with AF are 4 to 5 times more likely to have an ischemic stroke.2 Their annual rate of stroke is 5%, which accounts for 15% of all strokes in the United States.2,3 The left atrial appendage (LAA) is a trabeculated cul-de-sac that is responsible for more than 90% of thrombus formations in AF patients. 4 Because of these findings, LAA closure devices have been developed as an alternative to oral anticoagulant (OAC) therapy.The first generation of endocardial LAA occluders comprised 3 devices: the Percutaneous LAA Transcatheter Occlusion system (Plaato) (ev3 Inc.; Plymouth, Minn), the Watchman Left Atrial Appendage Closure Device (Boston Scientific Corporation; Natick, Mass), and the Amplatzer Cardiac Plug (ACP) device (St. Jude Medical, Inc.; Minneapolis, Minn). Plaato withdrew from the market in 2006, and the ACP is not yet available for commercial use in the U.S. 5The newer generation of endocardial LAA occluders comprises the WaveCrest ® LAA Occlusion System (Coherex Medical, Inc.; Salt Lake City, Utah), the LAmbre Left Atrial Appendage Occluder (Lifetech Scientific [Shenzhen] Co., Ltd.; Shenzhen, PRC), and the Ultrasept LAA Closure Device (Cardia Inc.; Eagan, Minn), none of which is available for commercial use in the U.S. 6 If you prefer to perform LAA closure through an epicardial approach, the Lariat ® Suture Delivery Device (SentreHeart, Inc.; Redwood City, Calif ) and the Aegis device (Aegis Medical Innovations Inc.; Vancouver, Canada) will permit that. But the Aegis device is available for investigational use only. 6 The Watchman Clinical Trial ExperienceThe Watchman LAA Closure Technology for Embolic Protection in Patients with Atrial Fibrillation (Protect AF) clinical trial was designed to examine the safety and efficacy of the Watchman device in patients with nonvalvular AF who were eligible for warfarin therapy and had a CHADS 2 stroke-risk score of 1 or greater.7 From February 2005 through June 2008, 707 patients at 59 centers in the U.S. and Europe were enrolled in the Protect AF study. The patients were randomly assigned in a 2:1 ratio to percutaneous closure of the LAA and subsequent discontinuation of warfarin (n=463), or to warfarin treatment. All patients were monitored for 12 months. The Protect AF trial showed that the Watchman LAA Closure is noninferior to warfarin for the combined endpoint of stroke, systemic embolism, and death, and it is a safe and effective alternative to OAC therapy in decreasing the risk of AF-related stroke. 7,8 The Protect AF trial showed a high rate (8.7%) of implant device-related sequelae, including perforations and pericardial effusions, and had a procedural failure rate of around 9%. However, most of these events occurred during the early stages of the trial, and procedural failure rates declined as surgeons became more experienced with the operation. According to the Protect AF trial, the U.S....

show abstract

Section: Lariat Studiesmentioning

confidence: 65%

Section: Lariat Studiesmentioning

confidence: 65%

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Where We Stand on Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation

Safavi‐Naeini¹,

Rasekh²

2016

Texas Heart Institute Journal

Self Cite

View full text Add to dashboard Cite

show abstract

“…The initial clinical experience demonstrated the efficacy of LAA closure with an acceptable safety profile [36]. The initial report was corroborated in 2 small single center studies that also demonstrated efficacy in LAA closure and safety with the LARIAT suture delivery device [37,38]. A prospective, multicenter observational study was initiated to assess whether LAA ligation in non-valvular AF patients at high risk for embolic events with ineligibility for oral anticoagulation would be a beneficial approach to reduce the risk of embolic events in this patient cohort [39].…”

Section: The Lariat Proceduresmentioning

confidence: 91%

Evolution of Catheter Based Therapies for Persistent and Long-Standing Persistent Atrial Fibrillation: The Amaze Trial

Badhwar¹,

Lee²

2017

Health Care Current Reviews

View full text Add to dashboard Cite

Atrial fibrillation (AF) is the most common arrhythmia of man and the incidence of AF increases with age. AF is known to increase the risk of stroke, heart failure and death. Patients with persistent and longstanding persistent AF generally do not respond to medications. Catheter ablation of AF is associated with a high rate of success in patients with paroxysmal AF. However, once a patient develops persistent or longstanding persistent AF, the outcomes of curing AF drop dramatically with catheter ablation. The development of new technologies and procedures has allowed physicians to perform catheter-based procedures that could previously be done only with cardiac surgery. One such technological development is the LARIAT procedure that allows cardiac electrophysiologists and surgeons to percutaneously exclude the left atrial appendage (LAA) and perform catheter ablation resulting in a percutaneous alternative to the open-chested surgical procedure, the Cox-Maze procedure. The AMAZE trial is a prospective, multi-center trial that was designed to evaluate the safety and effectiveness of the LARIAT procedure to percutaneously exclude the LAA; and to determine if LAA exclusion combined with catheter based pulmonary vein isolation improves maintenance of sinus rhythm in patients with persistent or long standing persistent AF. The mini-review will describe the epidemiology of AF, review current treatment of AF and provide the rationale and status for the AMAZE trial.

show abstract

“…The ongoing aMAZE trial comparing pulmonary vein isolation in combination with LAA ligation vs pulmonary vein isolation alone will address the safety issues as well as LARIAT’s effectiveness on maintenance of sinus rhythm in the difficult patient category of persistent and longstanding persistent AF 52. The device has also been investigated in AF patients who were ineligible for OAC therapy 53. In this trial in 139 patients, 99% acute successful LAA closure was observed, and at follow-up, 100% of the patients showed successful closure including leaks <5 mm.…”

Section: Current Therapeutic Strategies To Prevent Stroke In Afmentioning

confidence: 99%

Novel stroke risk reduction in atrial fibrillation: left atrial appendage occlusion with a focus on the Watchman closure device

Alipour

Wintgens

Swaans

et al. 2017

VHRM

View full text Add to dashboard Cite

Atrial fibrillation (AF) remains an important clinical problem with severe complications such as stroke, which especially harms those with risk factors as calculated by the CHADS 2 or CHA 2 DS 2 -VASc. Until now, no therapy has proven 100% effective against AF. Since the left atrial appendage (LAA) is the most prominent nonvalvular AF-related thromboembolic source and (novel) oral anticoagulant [(N)OAC] carries the hazard of bleeding, LAA occlusion may be an alternative, especially in patients who are ineligible for (N)OAC therapy. In this review, we discuss several LAA occlusion techniques with a focus on the Watchman device since this device is the most thoroughly studied device of all.

show abstract

Left Atrial Appendage Ligation in Nonvalvular Atrial Fibrillation Patients at High Risk for Embolic Events With Ineligibility for Oral Anticoagulation

Cited by 38 publications

References 48 publications

Where We Stand on Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation

Where We Stand on Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation

Evolution of Catheter Based Therapies for Persistent and Long-Standing Persistent Atrial Fibrillation: The Amaze Trial

Novel stroke risk reduction in atrial fibrillation: left atrial appendage occlusion with a focus on the Watchman closure device

Contact Info

Product

Resources

About